You are here
Orathecin NDA Withdrawn From FDA Consideration
SuperGen's decision to withdraw the filing was based on discussions with both the FDA and consultants helping the company dialog with the Agency regarding the Orathecin NDA.
Dr. James Manuso, Chairman, President and Chief Executive Officer of SuperGen, stated, "Based on the feedback we received, we decided it was best for the long-term development of Orathecin to withdraw the application. After we review the FDA's complete findings, we will determine the most appropriate course of action for Orathecin in the U.S."
Dr. Manuso added, "SuperGen's European filing remains on track, and our planned U.S. non-randomized portion of the Phase III trial of Orathecin and gemcitabine as a combination first-line therapy for advanced pancreatic cancer patients continues to move forward."
SuperGen originally submitted the NDA for Orathecin on January 26, 2004, with a target Prescription Drug User Fee Act (PDUFA) date of November 26, 2004. At the request of the FDA, the company recently submitted additional clinical data from a trial of Orathecin as a first-line treatment for pancreatic cancer as well as new analyses of data from the pivotal study in 2nd and 3rd line patients. The FDA classified these data as a Major Amendment, which triggered an extension of the review period by 90 days. The revised target PDUFA date was February 26, 2005.
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor.
Orathecin has Orphan Drug status in both the U.S. and EU for the treatment of pancreatic cancer. The Orathecin European filing or Marketing Authorization Application contains data from a Phase III clinical program believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 patients. Orathecin has also been evaluated in numerous other cancers and blood disorders.
Source: SuperGen, Inc.